Coola Spray
NDC Package 79753-033-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Coola (sunscreen face mist) sprays is sHAKE WELL before use.With your eyes completely closed, mist face evenly, holding bottle 10-12 inches away from face.Wait until dry.Apply liberally 15 minutes before sun exposure.Reapply:-After 80 minutes minutes of swimming or sweating-Immediately after towel drying-At least every 2 hoursSun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. This formulation utilizes a spray delivery system. Marketed by Coola Llc, this product is identified by NDC 79753-033 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
79753-033-01
Package Description
100 mL in 1 BOTTLE, PLASTIC
Product Code
79753-033
11-Digit Billing Format
79753003301

Clinical Specifications

Proprietary Name
Coola Spf 50 Classic
Non-Proprietary Name
Sunscreen Face Mist
Substance Name
Avobenzone; Octisalate; Octocrylene
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Usage Information
SHAKE WELL before use.With your eyes completely closed, mist face evenly, holding bottle 10-12 inches away from face.Wait until dry.Apply liberally 15 minutes before sun exposure.Reapply:-After 80 minutes minutes of swimming or sweating-Immediately after towel drying-At least every 2 hoursSun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other protection measures including:-Limit time in the sun, especially from 10 a.m. – 2 p.m.-Wear long sleeves shirts, pants, hats, and sunglasses.Children under 6 months: Ask a doctor.

Regulatory & Marketing

Labeler Name
Coola Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-02-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 79753-033-01 identifies a specific commercial package of 100 ml in 1 bottle, plastic of Coola Spf 50 Classic, a human over the counter drug labeled by Coola Llc. This spray is formulated for topical use and contains avobenzone; octisalate; octocrylene as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Coola Llc on November 02, 2021. The current certification is valid through December 31, 2026.

How is this Coola Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 79753003301. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
79753-033-01
11-Digit CMS (5-4-2)
79753-0033-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.